Relapse Prevention in Patients With a Major Depressive Episode Treated With Electroconvulsive Treatment Using a Fixed Dose Range of Escitalopram Compared to a Fixed Dose of Nortriptyline (DUAG-7) A Randomised Controlled 6 Month Double-blind Study
Overview
- Phase
- Phase 4
- Intervention
- escitalopram
- Conditions
- Major Depression
- Sponsor
- Hillerod Hospital, Denmark
- Enrollment
- 47
- Locations
- 1
- Primary Endpoint
- Hamilton depression rating scale
- Status
- Terminated
- Last Updated
- 11 years ago
Overview
Brief Summary
The main purpose of this study is to investigate the relapse preventing efficacy of escitalopram in a dose range and nortriptylin in a single dose in patients having been treated successfully with a course of electroconvulsive treatment (ECT).
Detailed Description
This study records severity of depression and relapse in patients treated for a major depressive disorder with electroconvulsive treatment (ECT)in a period og 6 month after end of ECT treatment. Patients will be randomized into four groups treated with escitalopram 10 mg, 20 mg, 30 mg or nortriptylin 100 mg daily dosages. The primary outcome measure is relapse and secondary outcome measure is tolerability. The study is a multicenter trial within Denmark.
Investigators
Klaus Martiny
Senior Consultant
Hillerod Hospital, Denmark
Eligibility Criteria
Inclusion Criteria
- •Remission from a major depressive episode after ECT treatment
Exclusion Criteria
- •Suicidality (Hamilton item 3 score of 3 or more)
- •Symptoms mania (MAS score of 15 or more)
- •Duration of actual depressive episode more than 2 years
- •Compulsory measures of any kind
- •Severe somatic illness
- •Pregnant or lactating subject
- •Known clinical relevant malabsorption.
- •Epilepsia
- •Clinically substantial cognitive deterioration due to ECT treatment
- •schizophrenia, schizopreniform or schizo-affective disorder
Arms & Interventions
Escitalopram 10 mg daily
Escitalopram 10 mg daily
Intervention: escitalopram
Escitalopram 20 mg daily
Escitalopram 20 mg daily
Intervention: escitalopram
escitalopram 30 mg daily
escitalopram 30 mg daily
Intervention: escitalopram
Nortriptylin 100 mg daily
Nortriptylin 100 mg daily
Intervention: nortriptyline
Outcomes
Primary Outcomes
Hamilton depression rating scale
Time Frame: 14 days
Secondary Outcomes
- Drop out due to side-effects of drugs(14 days)